Company: Beckman Coulter, Inc
Date of Enforcement Report: 6/23/04
Class: II
PRODUCT
DL 2000 Data Manager. Recall # Z-1027-04.
REASON
Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream.
CODE
Version 6.2.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on February 14, 2003. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
231 units.
DISTRIBUTION
Nationwide.
